A Study of the Cost Effectiveness of Generalist Care Managers for Depression Treatment in Medicaid Recipients
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Purpose
This project will enable the investigators to conduct a randomized clinical trial to demonstrate the value of generalist care managers in the treatment of depression in Medicaid patients seen in primary health care practices. Depressed patients will be recruited at two primary care practices in Western North Carolina and randomly assigned to either generalist care management or usual care. Patients in each condition will be assessed at baseline and six months follow-up. Outcomes will include depressive symptoms, level of functioning, and cost-effectiveness measures.
| Condition | Intervention |
|---|---|
|
Major Depressive Disorder |
Procedure: Generalist Care Manager vs Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial of the Cost Effectiveness of Generalist Care Managers for the Treatment of Depression in Medicaid Recipients |
- Baseline, 3 and 6-month Patient Health Questionnaire (PHQ9) scores
- Baseline and 6-month Short Form (SF)-12 scores, Medicaid claims data; patient perception of treatment by self-report; review of GCM case notes, physician and office staff time study; physician and office staff focus groups
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | February 2005 |
Randomized trial among depressed Medicaid patients aged 18 years and older in 2 primary care practices in Western NC comparing an intervention with a GCM to usual care (UC) between July 2003 and February 2005. GCMs, already providing diabetes and asthma services, were further trained and given ongoing supervision to provide algorithm–based depression care to enhance guideline concordant treatment. GCMs provided elements of self-management, decision support, use of information systems, and core care management components.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- scoring 10 or greater on PHQ-9 and primary care physician verification of major depression by clinical exam; and
- willing to begin or continue antidepressant medication
Exclusion Criteria:
- bipolar disorder, psychotic symptoms, or active suicidal ideation requiring psychiatric admission (
Contacts and Locations| United States, North Carolina | |
| Mountain Area Health Education Center (MAHEC) | |
| Asheville, North Carolina, United States, 28804 | |
| Hot Springs Health Program | |
| Marshall, North Carolina, United States, 28753 | |
| Principal Investigator: | Suzanne Landis, MD, MPH | University of North Carolina |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00373477 History of Changes |
| Other Study ID Numbers: | 03-fam/med-161, RWJF ID number: 048128 |
| Study First Received: | September 6, 2006 |
| Last Updated: | September 6, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
Depression Primary Care Care Manager |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013